Drugplain

SIGNATURE CARE Childrens Multi Symptom Cold 5 mg/5mL

Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride · SOLUTION · SAFEWAY

No Recall History
Plain English

SIGNATURE CARE Childrens Multi Symptom Cold is a solution containing dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride at 5 mg/5mL, taken oral. Manufactured by SAFEWAY.

Key Facts

Brand Name
SIGNATURE CARE Childrens Multi Symptom Cold
Generic Name
Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
NDC Code (Product)
21130-162
Manufacturer
SAFEWAY
Strength
5 mg/5mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Expectorant [EPC]
Marketing Start
01/16/2026

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

eye discharge1 reports
eye infection1 reports
eye irritation1 reports
eye pain1 reports
inappropriate schedule of product administration1 reports
ocular hyperaemia1 reports
suspected counterfeit product1 reports
therapeutic product effect variable1 reports
therapy cessation1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses ▪ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive ▪ temporarily relieves: ▪ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ▪ the intensity of coughing ▪ the impulse to cough to help your child get to sleep ▪ nasal congestion due to a cold ▪ stuffy nose

Dosage & Administration

Directions ▪ do not take more than 6 doses in any 24-hour period ▪ measure only with dosing cup provided ▪ do not use dosing cup with other products ▪ dose as follows or as directed by a doctor Age Dose children 6 years to under 12 years 10 mL every 4 hours children 4 years to under 6 years 5 mL every 4 hours children under 4 years do not use

Warnings

Warnings Do not use in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if the child has ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ cough that occurs with too much phlegm (mucus) ▪ persistent or chronic cough such as occurs with asthma When using this product do not use more than directed Stop use and ask a doctor if ▪ nervousness, dizziness or sleeplessness occur ▪ symptoms do not get better within 7 days or occur with fever ▪ cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Frequently Asked Questions

What is SIGNATURE CARE Childrens Multi Symptom Cold used for?

SIGNATURE CARE Childrens Multi Symptom Cold contains Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride. It is a solution taken oral. Consult your doctor for specific uses.

Is SIGNATURE CARE Childrens Multi Symptom Cold a controlled substance?

SIGNATURE CARE Childrens Multi Symptom Cold is not classified as a controlled substance by the DEA.

What is the generic name for SIGNATURE CARE Childrens Multi Symptom Cold?

The generic name for SIGNATURE CARE Childrens Multi Symptom Cold is Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride. There are 12 other brand versions of Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride.

What is the NDC code for SIGNATURE CARE Childrens Multi Symptom Cold 5 mg/5mL?

The NDC (National Drug Code) for SIGNATURE CARE Childrens Multi Symptom Cold 5 mg/5mL is 21130-162, listed by SAFEWAY.